Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Consulta CRT0P, Syncra CRT-P, Viva CRT-P
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: Medtronic, Inc.; 8200 Coral Sea St. N.E; Ms Mvs11; Mounds View, MN 55112
• PMA Number: P010015
• Supplement Number: S310
• Date Received: 09/26/2016
• Decision Date: 10/24/2016
• Product Code: LWP
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Extension of a continuous monitoring system for non-controlled manufacturing areas.